Irrisept C.Acnes Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-01-01

Brief Summary

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A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes

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Detailed Description

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The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.

Conditions

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Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Randomized, Controlled Trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Antiseptic Cleanser

Standard prophylaxis will be administered by Irrisept patients as would individuals in the control group. In addition, these Irrisept study subjects will be supplemented with the use of Irrisept irrigation by the study surgeon during the patient's surgical procedure. Standard times for irrigation will include immediately after incision through the dermal layer, and immediately prior to implantation of any prosthetic components. Final irrigation will be performed just prior to closure of the deltopectoral interval.

Group Type EXPERIMENTAL

Antiseptic Cleanser

Intervention Type DRUG

Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria.

Standard of Care Prophylaxis

Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antiseptic Cleanser

Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria.

Intervention Type DRUG

Other Intervention Names

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Irrisept Wound Cleansing System

Eligibility Criteria

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Inclusion Criteria

1. Patient has signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures
2. Patient can read and understand English
3. Patient who will undergo a primary shoulder arthroplasty
4. Patient is over the age of 18

Exclusion Criteria

1. Patient who has had a previous surgery on the ipsilateral shoulder
2. Patient has a known allergy to topical iodine or Chlorohexidine gluconate.
3. Patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery
4. Patient requires a revision procedure for a previous ipsilateral shoulder surgery
5. Patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation
6. Patient is a pregnant woman

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes